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A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.

NCT07268677 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-08

No results posted yet for this study

Summary

Assuming that the objective response rate (ORR) of neoadjuvant chemotherapy in patients with colorectal cancer peritoneal metastasis is approximately 0.40 , a total sample size of 30 patients is required.

Step 1:

Ten patients will be initially enrolled. If the number of responders (CR/PR) is \< 2, the study will be terminated early for futility.

If the number of responders is \> 8, the treatment regimen will be considered effective, and the study may be concluded early.

Step 2:

If the number of responders in Step 1 is between 2 and 8, the study will continue to enroll an additional 20 patients until completion.

Treatment regimen: CapeOX + Pirfenidone + Sintilimab

CapeOX:

Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks

Pirfenidone:

Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen)

Sintilimab:

200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply.

Tumor response evaluation will be performed after 4 treatment cycles.

Conditions

Interventions

DRUG

pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy

Treatment regimen: CapeOX + Pirfenidone + Sintilimab CapeOX: Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks Pirfenidone: Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen) Sintilimab: 200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply. Tumor response evaluation will be performed after 4 treatment cycles.

Sponsors & Collaborators

  • Guoxiang Cai

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-12-01
Completion
2027-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268677 on ClinicalTrials.gov